An appeals court has ruled against a legal challenge to the Drug Price Negotiation Program.
On Wednesday, the U.S. Court of Appeals for the Sixth Circuit sided with the Department of Health and Human Services in a case appealed from the Southern District of Ohio.
In the case brought by four chambers of commerce – the Michigan, Ohio, Dayton Area, and U.S. Chambers of Commerce – the appeals court agreed with the lower court in ruling that the Dayton Area and Ohio Chambers of Commerce lacked standing and proper venue to bring a valid legal challenge.
WHY THIS MATTERS
In August 2022, Congress passed the Inflation Reduction Act, giving the HHS secretary the ability to negotiate drug prices with manufacturers that sell to Medicare and Medicaid under the Drug Price Negotiation Program.
The chambers sued HHS on behalf of their pharmaceutical manufacturer members, challenging the constitutionality of the negotiation program.
"Plaintiffs claimed that the Program amounted to the government's attempt to 'displace market forces and set prices on targeted products through central planning,'" according to court documents.
Chamber members include AbbVie and subsidiary Pharmacylics, which makes Imbruvica, a drug to treat blood cancer. It was the first drug selected for the Drug Price Negotiation Program, according to court documents.
At the beginning of litigation in June 2023, Pharmacyclics was not a member of the Dayton or Ohio chambers, but joined in August 2023.
"The district court dismissed the case on its determination that neither the Dayton Chamber nor the Ohio Chamber satisfied the test for associational standing, making venue improper in Ohio," the appeals court said. "The court did not err in reaching that conclusion."
The next step would be for the U.S. Chamber to appeal the case to the Supreme Court, according to The Hill.
THE LARGER TREND
The case was originally dismissed in August 2024 by the federal court in Ohio.
Patients For Affordable Drugs (P4AD) said it submitted four amicus briefs on behalf of patients and signed onto seven briefs supported by Protect Our Care, Doctors for America, and Families USA to support the government's opposition to the lawsuits.
P4AD Executive Director Merith Basey said, "This decision marks the 10th court ruling in favor of patients and against the pharmaceutical industry's desperate legal attacks on the overwhelmingly popular Medicare Negotiation Program, which in January will deliver lower prices to more than 9 million patients across the nation."
Email the writer: SMorse@himss.org